Description
Manufacturers of animal food, Type A medicated articles, and medicated feeds use tracers to identify a particular product, to allow for determination of the presence of a particular ingredient, or for other purposes. Tracers are designed to be inert, harmless, and easily detectable. The purpose of this document is to provide guidance on the use of tracers in animal food, Type A medicated articles, and medicated feeds.
Scope & Applicability
Product Classes
2Guidance on the use of tracers in animal food, Type A medicated articles, and medicated feeds.
The primary product category covered by this guidance; Subject of the bioequivalence guidance for poorly soluble APIs.
Related CFR Sections (5)
- 21CFR225.58§ 225.58 Laboratory controls.
(a) The periodic assay of medicated feeds for drug components provides a measure of performance of the manufacturing process in manufacturing a uniform product of intended potency.Read full regulation →
- 21CFR514.8§ 514.8 Supplements and other changes to an approved application.
(a) Definitions.Read full regulation →
- 21CFR501.100§ 501.100 Animal food; exemptions from labeling.
(a) The following foods are exempt from compliance with the requirements of section 403(i)(2) of the act (requiring a declaration on the label of the common or usual name of each ingredient when the food is fabricated from two or more ingredients).Read full regulation →
- 21CFR501.4§ 501.4 Animal food; designation of ingredients.
(a) Ingredients required to be declared on the label of a food, including foods that comply with standards of identity that require labeling in compliance with this part 501, except those exempted by § 501.100 , shall be listed by common or usual name in descending order of predominance by weight onRead full regulation →
- 21CFR570.30§ 570.30 Eligibility for classification as generally recognized as safe (GRAS).
(a) General recognition of safety may be based only on the views of experts qualified by scientific training and experience to evaluate the safety of substances directly or indirectly added to food. The basis of such views may be eitherRead full regulation →
Related Warning Letters (5)
- 2025-04-29
Unapproved New Animal Drug Products
Holista LLC dba HolistaPet
- 2025-04-29
Unapproved New Animal Drug Products
Bailey’s Wellness, LLC dba Bailey’s CBD
- 2022-11-21
Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products
Infusionz, LLC
- 2022-05-26
Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products
Plantacea, LLC dba Kahm
- 2022-05-26
Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products
Haniel Concepts, Inc. DBA Free State Oils, LLC
See Also (8)
- Submission Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products: Guidance for Industry (Status: Final)
- CVM GFI #82 Development of Supplemental Applications for Approved New Animal Drugs (Status: Final)
- CVM GFI #126 BACPAC I-Intermediates in Drug Substance Synthesis Bulk Actives Postapproval Changes: Chemistry, Manufacturing, and Controls Documentation (Status: Final)
- CVM GFI #176 (VICH GL39) Specifications: Test Procedures and Acceptance Criteria for New Veterinary Drug Substances and New Medicinal Products: Chemical Substances (Status: Final)
- Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations (Status: Final)
- CVM GFI #83 Chemistry, Manufacturing and Controls Changes to Approved NADA/ANADA (Status: Final)
- Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products: Guidance for Industry (Status: Final)
- CVM GFI #213 New Animal Drugs and New Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water of Food-Producing Animals: Recommendations for Drug Sponsors for Voluntarily Aligning Product Use Conditions with GFI #209 (Status: Final)